(51 days)
The Flex Body SPEEDER is intended for use with Canon 3.0T MR systems to produce diagnostic images of general human anatomy that can be interpreted by a trained physician.
The Flex Body SPEEDER is a receive-only, phased array coil designed for magnetic resonance imaging (MRI) using the Canon 3T MR systems. The Flex Body SPEEDER is intended to be used for imaging general human anatomy, such as the torso, pelvis, joints, bones and extremities. The Flex Body SPEEDER is a reusable, non-invasive device with limited exposure with regard to duration of contact with the body. The coil elements are encapsulated in polycarbonate and aramid felt which are fire-rated and provide impact and tensile strength, then covered with a polyurethane coated nylon fabric which has been evaluated for biocompatibility.
The provided text describes the Flex Body SPEEDER, a receive-only, phased array coil for MRI, and its performance testing. However, it does not include detailed acceptance criteria or a specific study designed to prove the device meets those criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity).
The "Performance Data" section discusses various types of testing but focuses on safety, electromagnetic compatibility, and basic image quality metrics (SNR and uniformity) rather than diagnostic efficacy.
Here's a breakdown of the information that is available and what is missing based on your requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Safe use in previously-cleared devices; identical material/processing | All surface materials similar to previously-cleared devices; identical formulation, processing, sterilization, geometry; no additional chemicals. |
| Electrical Safety | Compliance with AAMI/ANSI ES60601-1 and IEC 60601-2-33 | Found compliant. |
| Surface Heating | Maximum surface temperature ≤ 41°C | Never exceeded 41°C. |
| Electrostatic Discharge Immunity | Compliance with IEC 60601-1-2 Ed 4.0 (2014) | Found compliant. |
| SNR (Bench Test) | Conforms to predetermined acceptance criteria (not specified) | Found to conform to predetermined acceptance criteria. |
| Uniformity (Bench Test) | Conforms to predetermined acceptance criteria (not specified) | Found to conform to predetermined acceptance criteria. |
| Clinical Image Quality | Diagnostic quality images of intended anatomies (no specific metric) | Clinical images from volunteer scanning demonstrated diagnostic quality for intended anatomies. |
Missing Information/Cannot Determine from Text:
- Specific quantitative acceptance criteria for SNR, uniformity, or what constitutes "diagnostic quality images."
- Specific metrics or thresholds used to evaluate "diagnostic quality images."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states "clinical images from volunteer scanning." The exact number of volunteers or images is not specified.
- Data Provenance: The text states "volunteer scanning," which implies a prospective collection of data. There is no information about the country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided. The text mentions "images can be interpreted by a trained physician," but it doesn't detail how multiple experts were used to establish a ground truth for specific diagnostic findings in the context of a performance study.
4. Adjudication Method for the Test Set
- This information is not provided. Given that no specific diagnostic performance study with expert review is detailed, an adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done (or at least not detailed in this document). The document focuses on demonstrating that the device produces diagnostic quality images on its own, not on comparing human readers with and without AI assistance. The Flex Body SPEEDER is an MRI coil, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Again, the Flex Body SPEEDER is an MRI coil, not an algorithm. The clinical performance discussed is about the images produced by the coil, which are then interpreted by a trained physician. So, there isn't a "standalone algorithm" performance in the sense of AI. The closest analogous information is the bench testing for SNR and uniformity and the review of clinical images for diagnostic quality, where the coil is performing "standalone" in terms of image acquisition quality.
7. Type of Ground Truth Used
- For the "Performance Testing - Clinical," the "ground truth" for "diagnostic quality images" appears to be the subjective assessment by a trained physician that the images are clear enough for diagnosis. It is not based on pathology, outcomes data, or expert consensus in a formal sense of diagnostic accuracy comparison. For the bench tests (SNR, uniformity), the ground truth is against predetermined acceptance criteria based on NEMA MS-6 and NEMA MS-9 standards.
8. Sample Size for the Training Set
- This information is not applicable/provided. The Flex Body SPEEDER is a physical MRI coil, not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/provided for the same reason as point 8.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.